FDA 510(k)

TENS&EMS (HZ9151B, HZ9151C, HZ9151D)

Номер K: K253740 · 2025-12-23

ЗаявительHong Qiangxing (Shenzhen) Electronics Limited

Дата решения2025-12-23

Код продуктаNUH

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is the device name listed in this FDA 510(k) record. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253740. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Hong Qiangxing (Shenzhen) Electronics Limited. The 510(k) number is K253740.

When did TENS&EMS (HZ9151B, HZ9151C, HZ9151D) receive FDA 510(k) clearance?

TENS&EMS (HZ9151B, HZ9151C, HZ9151D) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253740.

Who is the listed applicant for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA 510(k) record lists Hong Qiangxing (Shenzhen) Electronics Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D)?

The FDA product code for TENS&EMS (HZ9151B, HZ9151C, HZ9151D) is NUH.

Другие записи, где Hong Qiangxing (Shenzhen) Electronics Limited указан как заявитель

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

K220283TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)K220152TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)K220150TENS & PMS (Model: SM9126)K201354TENS & PMS K190009Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)K183154SM Electrodes

Посмотреть все 7 устройств →

Связанные устройства (Код: NUH)

K261131Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)Shenzhen Osto Medical Technology Co.,Ltd K260412TENS 7000 Rechargeable 4 Channel (TENS 7000H)Shenzhen Dongdixin Technology Co., Ltd.K260425TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237)Hivox Biotek, Inc.K253896TENS/EMS device (GUSE01)Globalcare Medical Technology Co., Ltd.K253305TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)Shenzhen Jiantuo Electronics Co., Ltd.K251958VEINOPLUS BackDynapulse Medical

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.